Is Myopathy Part of Statin Therapy (IMPOSTER-16)
Myopathic Conditions
About this trial
This is an interventional diagnostic trial for Myopathic Conditions focused on measuring rhabdomyolysis,, myositis,, myopathy,, statin side effects,, fatty acid oxidation, Statin induced Muscle toxicity
Eligibility Criteria
Inclusion Criteria: Primary doctor's permission Patient understands nature of study and has signed consent Patient is >21 years of age Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration Patient able to perform the strength and functional tests required Patient complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy CK < 350 IU Thyroid stimulating hormone (TSH) must be normal Fasting respiratory exchange ratio (RER) > 0.80 off statin for at least 4 weeks Exclusion Criteria: Severe underlying illness including: Cr > 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing. History of muscle damage (CK > 350 IU) on statins Underlying musculoskeletal disorder preventing muscle testing History of severe depression Taking doses of other medicines with statin sufficient to cause myopathy including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily. Diabetes requiring other than diet therapy Use of thiazolidinediones (TZD's), protease inhibitors or other drugs known to influence RER or fatty acid oxidation. Abnormal thyroid status Inability to maintain constant exercise, dietary, and drug regimen during the 16 weeks required by the study protocol.
Sites / Locations
- Scripps Mercy Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
1
2
statin administration